Health Education Using Text Messaging Prevents Hypertension in High Risk People

Hypertension Clinical Trial

Official title:

Health Education Using Text Messaging Prevents Hypertension in High Risk People: a Comparison Between Effectiveness of Electronic Text Messaging and Printed Material

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02551926
• Other study ID #: QUMS25
• Status: Recruiting
• Phase: N/A
• First received: August 27, 2015
• Last updated: September 15, 2015
• Start date: August 2015
• Est. completion date: December 2015

Study information

• Verified date: September 2015
• Source: Qazvin University Of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Prehypertension is a predisposing condition for morbidity inhypertension and cardiovascular diseases. Health education via electronic pathways such as mobile text messaging or virtual communities may provide more availability and adherence than printed media. Regarding lower costs of such electronic resources and continuity of interventions through these ways, assessing their effectiveness compared to a printed material may help health educators to choose proper methods for improve their educational attempts. Therefore, the current study aims to compare different tools for health education about healthy lifestyle in people with prehypertension. For this, educational interventions with similar content among 3 groups of people will be conducted (i.e., first group via mobile text messaging, second group using virtual communities, and third group by brochures as a printed media). A control group also will be considered without any intervention. Several phases are considered in the study. In phase 1 using health centers located in Qazvin city, people would be invited to a free screening program of prehypertension. Then, an eligible sample will be divided in three groups using a random allocation process (each one including 100-150 people with prehypertension). The blood pressure and health promotion lifestyle profile II (HPLP II) will be measured before intervention. A standard educational content using approaches of lifestyle promotion defined in HPLP II would be available for intervention groups during a time period of 1 month concurrently. At final phase, one month after termination of intervention blood pressure as primary outcome and lifestyle changes along with self-efficacy for lifestyle modification as secondary outcomes will be measured. This study may suggest effective ways for health education which is applicable by health care professionals to promote health status among peopleat risk of hypertension.

Description:

Prehypertension is a predisposing condition for morbidity in hypertension and cardiovascular diseases. This has been defined as a systolic pressure from 120 to 139 mmHg or a diastolic pressure of 80-89 mm hg. The prevalence of this condition estimated to be at least 2 times higher than hypertension and those who have prehypertension 4 times more likely to progress to hypertension than normotensive people. Although, hypertension is a multi-factorial disease, lifestyle is associated mainly to its development. According to information, lifestyle changes may prevent more than 70% of primary hypertension and health education is a key strategy to promote lifestyle modification. Health education via electronic pathways such as mobile text messaging or virtual communities may provide more availability and adherence than printed media. Regarding lower costs of such electronic resources and continuity of interventions through these ways, assessing their effectiveness compared to a printed material may help health educators to choose proper methods for improve their educational attempts. Therefore, the current study aims to compare different tools for health education about healthy lifestyle in people with prehypertension. For this, educational interventions with similar content among 3 groups of people will be conducted (i.e., first group via mobile text messaging, second group using virtual communities, and third group by brochures as a printed media). A control group also will be considered without any intervention. Several phases are considered in the study. In phase 1 using health centers located in Qazvin city, people would be invited to a free screening program of prehypertension. Then, an eligible sample will be divided in three groups using a random allocation process (each one including 100-150 people with prehypertension). The blood pressure and health promotion lifestyle profile II (HPLP II) will be measured before intervention. A standard educational content using approaches of lifestyle promotion defined in HPLP II would be available for intervention groups during a time period of 1 month concurrently. At final phase, one month after termination of intervention blood pressure as primary outcome and lifestyle changes along with self-efficacy for lifestyle modification as secondary outcomes will be measured. This study may suggest effective ways for health education which is applicable by health care professionals to promote health status among people at risk of hypertension.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• be >18 years

• have a diagnosis of prehypertension based on definition

• own a cell phone capable of receiving and sending text messages

• be a member of virtual communities

• Persian speaking

• willing to attend two data collection visits in Qazvin

Exclusion Criteria:

• admits to planning to terminate cell phone contract or excite form virtual communities during the next one month

• education less than primary school

• other major health problems (e.g., terminal stage of cancer, advanced liver disease)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension

Intervention

Behavioral:
• mobile text messages

• virtual community

• brochures

Other:
• Usual care

Device:
• mobile phone

Locations

Country	Name	City	State
Iran, Islamic Republic of	22 Bahman Hospital	Qazvin
Iran, Islamic Republic of	Qazvin University of Medical Sciences, Shahid Rajaei Hospital	Qazvin

Sponsors (1)

Lead Sponsor	Collaborator
Qazvin University Of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure		Changes from baseline and 1 Months after the intervention	Yes
Secondary	changes in self-reported physical activity	Physical activity will be measured using a self-reported scale examining participants' self- reported physical activity for the past seven days. Six items	Changes from baseline and 1 Months after the intervention	Yes
Secondary	Changes in self-reported healthy eating	Healthy eating behavior will be measured using the Diet Guidelines Index (DGI). The DGI is a food-based dietary index that measures adherence to healthy eating recommendations over the previous month. It consists of 15 items that reflect current dietary guidelines,including consumption of vegetable and legumes, fruit, total cereals, meat, total dairy, beverages, sodium, saturated fat, alcoholic beverages, and added sugars. A diet quality score is obtained by summing the indicators of wholegrain cereals, lean meat, low-fat dairy, and dietary variety, and is informed by age- and sex-specific recommendations. Scores range from 0 to 150, with higher scores representing higher levels of healthy eating. Serving portions are described in the questionnaire, and participants were directed to refer to the healthy eating guidelines26 provided for further details.	Changes from baseline and 1 Months after the intervention	Yes
Secondary	Changes in self-reported Self-efficacy	Self-efficacy will be measured using the Medication Adherence Self-Efficacy Scale (MASES).he MASES is a patient-centered and self-administered questionnaire that consists of 26 items. The patient were asked to rate their confidence of taking antihypertensive medications in different conditions using a three-point scale	Changes from baseline and 1 Months after the intervention	Yes